Primary Operation in synchronous metastasized invasive breast cancer to evaluate the use of local therapy
This study is a prospective, randomized, multicentre, study concerning the influence of local treatment on the patients with synchronous metastasized breast cancer. Patients will be stratified at inclusion according to the centre, the menopausal status (pre-menopausal, post-menopausal), the hormone-receptor status (ER-/PR-/not determinable; any PR and/or Er+), the HER-2 status (positive vs. negative/not determinable), the grading (G1/G2/not determinable vs. G3), location of metastases (visceral ± vs bone only), organs with metastases (single organ vs multiple organs) and use of first line chemotherapy (anthracycline ± vs. taxane vs others). Thereafter patients will be randomly assigned to receive either local therapy of the breast (lumpectomy or mastectomy + axillary surgery /± radiotherapy) versus no local therapy. Systemic therapy will be administered at the centers policy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
90
lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II)
if necessary local therapy on demand
Hospital Guessing
Güssing, Burgenland, Austria
Hospital Oberpullendorf
Oberpullendorf, Burgenland, Austria
Ordination Dr. Wette
Saint Veit A. D. Glan, Carinthia, Austria
Overall Survival (OS)
Overall Survival with vs without local therapy (surgery)
Time frame: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months
Time to Distant Progression
Time to distant progression with vs without local therapy (surgery)
Time frame: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months
Time to Local Progression (TTPl)
Time to local progression with vs without local therapy (surgery)
Time frame: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months
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Gynaegological Medical University Graz
Graz, Styria, Austria
Medical University Graz, Oncology
Graz, Styria, Austria
Medical University of Innsbruck
Innsbruck, Tyrol, Austria
Ordensklinikum Linz GmbH - BHS Linz, Coop. Study Group
Linz, Upper Austria, Austria
Ordensklinikum Linz GmbH - Elisabethinen Linz
Linz, Upper Austria, Austria
General Hospital Linz
Linz, Upper Austria, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Upper Austria, Austria
...and 4 more locations